Respiree Cardio-Respiratory Monitor— 510(k) K223681

Name: FDA 510(k) clearance K223681
Creator: U.S. Food and Drug Administration
Published: 2023-03-08

Substantially Equivalent

Respiree Pte, Ltd.

FDA 510(k) clearance K223681 for Respiree Cardio-Respiratory Monitor, Substantially Equivalent on 2023-03-08. Applicant: Respiree Pte, Ltd.. Device class: 2.

Clearance details

Applicant: Respiree Pte, Ltd.
Product code: Code BZQ
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 2022-12-08
Decision date: 2023-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Singapore, SG

Download summary PDF View on FDA.gov ↗

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